Status:
COMPLETED
SYMPLICITY HTN-3 Renal Denervation in Patients With Uncontrolled Hypertension
Lead Sponsor:
Medtronic Vascular
Conditions:
Uncontrolled Hypertension
Eligibility:
All Genders
18-80 years
Phase:
NA
Brief Summary
The Symplicity HTN-3 study is a, multi-center, prospective, single-blind, randomized, controlled study of the safety and effectiveness of renal denervation in subjects with uncontrolled hypertension. ...
Detailed Description
The Symplicity HTN-3 study is a, multi-center, prospective, single-blind, randomized, controlled study of the safety and effectiveness of renal denervation in subjects with uncontrolled hypertension. ...
Eligibility Criteria
Inclusion
- Individual is ≥ 18 and ≤ 80 years old at time of randomization.
- Individual is receiving a stable medication regimen including full tolerated doses of 3 or more anti-hypertensive medications of different classes, of which one must be a diuretic (with no changes for a minimum of 2 weeks prior to screening) that is expected to be maintained without changes for at least 6 months.
- Individual has an office systolic blood pressure (SBP) of ≥ 160 mmHg based on an average of 3 blood pressure readings measured at both an initial screening visit and a confirmatory screening visit
Exclusion
- Individual has an estimated glomerular filtration rate (eGFR) of \< 45 mL/min/1.73 m2
- Individual has an Ambulatory Blood Pressure Monitoring (ABPM) 24 hour average SBP \< 135 mmHg
- Individual has type 1 diabetes mellitus
- Individual requires chronic oxygen support or mechanical ventilation (e.g., tracheostomy, CPAP, BiPAP) other than nocturnal respiratory support for sleep apnea.
- Individual has primary pulmonary hypertension.
- Individual is pregnant, nursing or planning to be pregnant.
Key Trial Info
Start Date :
September 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 17 2017
Estimated Enrollment :
535 Patients enrolled
Trial Details
Trial ID
NCT01418261
Start Date
September 1 2011
End Date
February 17 2017
Last Update
April 26 2017
Active Locations (79)
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1
Cardiology, PC
Birmingham, Alabama, United States, 35211
2
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35294
3
Scripps Clinic/Scripps Green Hospital
La Jolla, California, United States, 92037
4
Kaiser Permanente - Los Angeles Medical Center
Los Angeles, California, United States, 90027